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To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

Phase 3
Completed
Conditions
Primary Hypercholesterolemia
Interventions
Drug: Livalo, Ezetrol
Registration Number
NCT04584736
Lead Sponsor
JW Pharmaceutical
Brief Summary

To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.

Detailed Description

A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
283
Inclusion Criteria
  • Patients with primary hypercholesterolemia
Exclusion Criteria
  • The subject not meet the specified LDL-C level

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Livalo 2mg, Ezetrol 10mgLivalo, EzetrolPitavastatin 2mg, Ezetimibe 10mg
Livalo 2mgLivalo, EzetrolPitavastatin 2mg
Livalo 4mg, Ezetrol 10mgLivalo, EzetrolPitavastatin 4mg, Ezetimibe 10mg
Livalo 4mgLivalo, EzetrolPitavastatin 4mg
Primary Outcome Measures
NameTimeMethod
% change in LDL-C level from baseline at Week 8Week 8

change in LDL-C level

Secondary Outcome Measures
NameTimeMethod
Change in LDL-C level from baseline at Week 4 and Week 8Week 4 and Week 8

change in LDL-C level

Trial Locations

Locations (1)

Gangdong Sacred Heart Hospital

🇰🇷

Seoul, Korea, Korea, Republic of

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